Cancer is the second leading cause of death in the U.S. after heart disease. The American Cancer Society predicts that more than 1.3 million new cancers will be diagnosed in 2003. This prediction does not even include non-invasive cancers and basal and squamous cell skin cancers. It is predicted that over 500,000 Americans will die from cancer this year alone.
Tremendous effort and resources are directed toward diagnosing and treating cancer. More than half of all cancers are susceptible to screening and early detection procedures, with resultant increases in survivability. It is estimated that if all cancers amenable to screening were detected in their early stages, survivability would increase to around 95%.
Diagnosis and treatment of cancer has progressed tremendously over the past several years. At one time, diagnosis of a tumor as “benign” or “malignant” was believed sufficient for a physician to plan and implement a course of treatment. However, cancer is not a single disease that responds well to a single treatment regimen. There are more than 300 distinctly identified types of tumors. Further, tumors have a course of development, a “maturing process”, and therefore it is also important to identify at what stage of growth the tumor is for predicting outcome and choosing the proper treatment strategy. Options for therapy have also greatly increased in recent years with regimens more directly tailored for specific types of tumors at particular stages of development. Therefore, it is more important than ever to have detailed information about an identified tumor in order to achieve the best outcome for a patient.
Using techniques of gross and microscopic examination of excised tissue, surgical pathologists play a vital role in gathering the information about type and stage of a tumor needed by a physician to plan a treatment course for the patient. Recent advances in molecular pathology related to a greater understanding of the specific genetic changes cells undergo to become cancerous promises to provide valuable information useful for designing treatment courses that are better tailored to the particular needs of an individual patient. This will provide a greater chance of survivability with less side effects and unnecessary suffering for the patient. For example, presently, if a mass is discovered in the breast of a patient, the mass is often surgically excised and analyzed to determine if it is cancerous. If so, the preferred course of treatment is often chemotherapy, which can have severe side effects. However, studies suggest that only 10% of patients treated with chemotherapy actually benefit from the treatment. Therefore, up to 90% of those undergoing chemotherapy may be suffering the side effects needlessly. Unfortunately, it is necessary, since gross and microscopic pathological analysis of the tumor cannot differentiate which patients will or will not benefit from the treatment.
As our understanding of the underlying genetic mechanisms of specific cancers increases, molecular pathological analysis of tumors will provide additional information to a physician so that a treatment regimen better tailored to the specific needs of an individual patient can be developed. This will increase chances for a positive outcome and decrease unnecessary suffering due to side effects.
Molecular pathology now plays a small role in identifying tumors and planning treatment strategies, however, this will undoubtedly change as more information about the underlying genetics of tumors comes to light. In the very near future, it will become necessary to divert portions of excised tumors for molecular testing.
At present, a majority of the demand for tumor samples related to molecular pathology is in basic and applied research directed at linking genetic findings to clinically observed pathology. Sources of tumor tissue for research are generally limited to tumor banks. Although these banks have been an immensely valuable source of materials and information for molecular analysis of tumors, for a number of reasons, the amount of useful data that can be collected is limited. First, a majority of the tissue found in tumor banks is from large tumors. Since genetic expression changes during different stages of tumor development, testing of larger tumors only does not provide a complete picture of tumor “lifecycles”. Furthermore, clinical screening for tumors in patients is becoming more precise, and therefore a greater majority of tumors found are smaller, and thus poorly represented by tumor bank specimens.
Second, the tissue is preserved, and so the amount of time lapsed between harvesting the tissue and preserving it is often unknown. Gene expression can change after removal of tissue from a patient as cells become anoxic and shift metabolism or even begin a shutdown of cell function. Thus, analysis of tissue aged prior to study may present a genetic expression profile greatly altered from what is found in a tumor intact in a patient. Also, preservation methods and reagents can adversely affect expressed proteins in the sample cells and obscure data.
Rather than rely on samples from tumor banks, tissue can instead be collected after gross and microscopic pathological analysis of a specimen. Again, however, significant time may pass between excision of the tissue and molecular testing to know the results are trustworthy. Thus, it is preferable to perform molecular analysis on tissue within minutes after excision of the tumor or on tissue immediately frozen after excision.
Although it is preferable to perform molecular analysis on tissue immediately after excision of a tumor, scientific progress should not come at the detriment of the immediate needs of the individual patient. Collection of tissue from a newly excised tumor could result in a loss of structural integrity of the tumor, thus preventing proper pathological analysis needed to classify the tumor type and stage. Further, a long delay between excision of the tumor and pathological analysis due to sampling tissue for molecular analysis could adversely affect the patient as well. Also, transfer of the tissue between too many hands could corrupt the integrity of the specimen, create a biohazard risk, and bring the results of the pathological analysis into question.
Accordingly, there is a long-felt need for a device for collecting small tissue specimens from suspected tumors immediately after excision from the patient for molecular analysis that is easy and safe enough to be used by operating room personnel immediately upon excision and in such a way that the pathologist receiving the tumor knows with accuracy from where the specimen was taken. The sampling device must not significantly alter the tumor structure so as to compromise the gross and microscopic pathological analysis. Most suitably, the device should maintain the specimen in the exact orientation in which it resided when it was removed from the patient. This ensures that the radiologist can better determine the location of a mass within the sample or that the pathologist can accurately determine margins and better direct the surgeon, should further excision of tissue be required in order to remove the entire suspect region of tissue.
The prior art discloses a variety of devices available for securing and transporting excised tissues for pathologic and/or radiologic evaluation. For example, tissue samples can be sandwiched between two plates, with the plates forming a grid for locating a mass within a tissue sample during subsequent radiological and pathological evaluation, as taught in U.S. Pat. No. 5,002,735 to Alberhasky et al. Although this device immobilizes the specimen, it does not prevent fluids from leaking since the sides of the carrier are open. Further it does not provide a means for sampling the tissue immediately after excision and immobilization without removing one of the plates. U.S. Pat. No. 6,225,107B1 to Nagle also discloses a device for immobilizing an excised specimen comprising an outer box with an open end and an inner box that is sized to slidingly insert into the open end of the outer box. The specimen is first inserted into the outer box and then compressed to a fixed position when the inner box is inserted into the open end of the outer box. This device does not provide for a means of sampling the tissue after immobilization. Further, the only means of securing the tissue in place is by a cumbersome technique of suturing the two boxes together. Neither of the prior art devices have a geometric conformation ideally suited for sampling of the tissue contained within from any angle, regardless of how the specimen is positioned.
Therefore, there is a long-felt need for a device for securing an excised tissue in a fixed position, for transport, radiography and pathological analysis, while also facilitating collection of samples for molecular analysis immediately after excision without destroying structural integrity of the specimen. Applicants have invented such a device.